GCP Study Excellence Lead

As a Clinical Quality Compliance Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Oversee and manage overall TMF performance and processes, including risk-based oversight strategies and adherence to TMF Plan and TMF Index, to ensure compliance and inspection readiness, including the cross-functional study team and outsourced elements to the CRO.
• Manage and guide teams on inspection readiness planning, including developing and maintaining inspection readiness plans and tools in collaboration with cQA and GCP Excellence in Clinical Trials leadership.
• Facilitate development of key inspection deliverables including but not limited to required listings, functional presentations, issue related storyboard development, and study team preparation for audits and inspection
• Lead and participate in Strategy Team Meetings and Lead Core Team Meetings for assigned projects
• Provide just-in-time guidance to study teams on key operating model processes and required documentation, prioritizing real-time inspection readiness
• Action compliance monitoring signals and study health metrics with teams to mitigate real-time issues
• Engage appropriate Sponsor and CRO SMEs in inspection readiness activities and study-level risk assessment investigations
• Ensure effective communication and issue escalation internally and externally with vendors
• Maintain project management documentation such as plans, timelines, and progress reports for ongoing inspection readiness
• Coordinate key activities to enable study team readiness for internal study audits and regulatory inspections,  including management of required listings and study team preparedness  
• Manage functional teams during inspections, collaborate with SMEs, provide follow-up, and ensure timely fulfillment of requests and responses.
• Facilitate and monitor study-specific CAPA related activities in collaboration with GCP Compliance Management and QA
• Identify and implement improvements in inspection readiness and study execution processes.
• Provide regular status updates to stakeholders and leadership.
• Ensure alignment with functional SMEs and cQA in real time throughout study lifecycle and during audits and inspections.

You are:

• Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field
• Experience working in the study team environment, with CROs and outsourced clinical trial activities, Sponsor experience preferred
• Experience in clinical trials systems management and oversight (Veeva Vault TMF preferred)
• Solid knowledge of and experience in GCP compliance, regulatory inspection readiness and study execution processes
• Solid knowledge of drug development and clinical trial processes, including related standards and documents.
• Proven awareness of sponsor oversight requirements and regulations
• Strong project management and communications skills to effectively assess risks, establish priorities, take initiative, and meet deadlines
• Must be able to work in a fast-paced, changing environment with demonstrated ability to prioritize multiple competing tasks and demands
• Solid knowledge of regulatory requirements governing clinical trials and industry best practices
• Bachelor’s degree preferred or commensurate with experience
• Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.